Cleared Traditional

K954512 - RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM

K954512 is an FDA 510(k) clearance for RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM, manufactured by Lifecore Biomedical, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K954512 · Lifecore Biomedical, Inc. · Dental device
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Feb 1996
Decision
148d
Days
Class 2
Risk

K954512 is an FDA 510(k) clearance for the RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on February 23, 1996 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Lifecore Biomedical, Inc. devices

FDA 510(k) Submission Details - K954512

510(k) Number K954512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1995
Decision Date February 23, 1996
Days to Decision 148 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 127d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1266
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K954512.
5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
K955619 · Calcitek, Inc. · Mar 1996
INTERPORE THREADED IMPLANT
K960371 · Interpore Intl. · Mar 1996
PHOENIX 4.0 MM HA COATED DENTAL IMPLANT
K931647 · Vancouver Implant Center · Mar 1996
3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955427 · Implant Innovations, Inc. · Feb 1996
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943604 · Calcitek, Inc. · Feb 1996
3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955428 · Implant Innovations, Inc. · Feb 1996